Chongqing ROB Linka Science AND Technology Co., Ltd.
Registered establishment in Chongqing, China. 9 device types, 4 clearances.
Chongqing ROB Linka Science AND Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Pad, Heating, Powered and 7 other device types. Its earliest product listing with the FDA dates from 2022.
9device types registered with the FDA
4510(k) clearances
Registration
| Registered name | CHONGQING ROB LINKA SCIENCE AND TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3025367760 |
| FEI number | 3025367760 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 重庆市罗布琳卡科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Chongqing |
|---|---|
| Province | Chongqing |
| Address | B3-1-2, Liangjiang Health Science and Technology City, No. 2 Yuekang Road |
| Postal code | 400700 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cable, Electrode | Class 2 | Electrode cable | 2022 | 47 |
| Massager, Therapeutic, Electric | Class 1 | Electric Massager | 2022 | 437 |
| Massager, Therapeutic, Manual | Class 1 | Massager | 2022 | 113 |
| Pad, Heating, Powered | Class 2 | Powered heating pad; Heating Kneepad; Heating Vest; Heating Gloves; Heating Jacket, Heating Blanket; Heating Belt; Heating Massage Belt | 2022 | 144 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | 2024 | 22 |
| Stimulator, Muscle, Powered | Class 2 | beurer TN 06, Wireless TENS & EMS (Model SM9110, SM9113, SM9116), Joint Stimulator; Transcutaneous Electrical Nerve Stimulator Model SM9116, TheraSTIM RTM, Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | 2024 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | beurer TN 06, Wireless TENS & EMS (Model SM9110, SM9113, SM9116), Joint Stimulator; Transcutaneous Electrical Nerve Stimulator Model SM9116, TheraSTIM RTM, Tens & PMS, Smart Muscle Training Wearables (Model:SM9027, SM9027, SM9566, SM9065N) and 9 more | 2022 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | beurer TN 06, Wireless TENS & EMS (Model SM9110, SM9113, SM9116), Joint Stimulator; Transcutaneous Electrical Nerve Stimulator Model SM9116, TheraSTIM RTM, Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | 2024 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | beurer TN 06, Wireless TENS & EMS (Model SM9110, SM9113, SM9116), Joint Stimulator; Transcutaneous Electrical Nerve Stimulator Model SM9116, TheraSTIM RTM, Tens & PMS, TENS Device and 11 more | 2022 | 57 |
Clearances
4 clearances name Chongqing ROB Linka Science AND Technology Co., Ltd. as applicant. 6 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233067 | 2024-07-19 | NUH | Traditional | This company |
| K233070 | 2024-03-13 | NGX | Traditional | This company |
| K233092 | 2024-02-12 | NUH | Traditional | This company |
| K230829 | 2023-04-26 | NUH | Traditional | This company |
| K220283 | 2022-05-02 | NUH | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K220150 | 2022-02-17 | NUH | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K201354 | 2020-12-11 | NGX | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K190009 | 2019-12-02 | NUH | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K133979 | 2014-08-26 | NUH | Traditional | Sunmas (H.K.) Trading Limited |
| K121719 | 2013-05-10 | NGX | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2018 |
|---|---|
| Main products | TENS pain management devices, EMS muscle stimulation equipment, Medium-frequency physiotherapy devices, tDCS head massage devices, Beauty devices |
| Certifications | ISO13485, FDA 510(k), FCC, MDSAP, CE, BSCI |
| Export markets | 40+ countries in Europe, America, Australia |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.